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Norgestimate, sold under the brand name Ortho Tri-Cyclen among others, is a progestin medication which is used in birth control pills for women and in menopausal hormone therapy. [ 1 ] [ 3 ] [ 4 ] [ 5 ] The medication is available in combination with an estrogen and is not available alone. [ 6 ]
In 1989, the FDA approved Ortho Cyclen containing the first new progestin (norgestimate) approved in over 20 years in the United States. In 1992, Ortho introduced Ortho Tri-Cyclen in the United States, which in 1996 became the first oral contraceptive with an FDA-approved non-contraceptive indication (treatment of moderate acne).
All contain an estrogen, ethinylestradiol or mestranol, [1] [2] in varying amounts, and one of a number of different progestogens. (Regarding the estrogen, the inactive 3-methyl ether of ethinylestradiol, which must be metabolized by the liver into the active ethinylestradiol; 50 μg of mestranol is equivalent to only 35 μg of ethinylestradiol and should not be used when high-dose [50 μg ...
This is a list of progestogens (progesterone and progestins) and formulations that are approved by the FDA Tooltip Food and Drug Administration in the United States. . Progestogens are used as hormonal contraceptives, in hormone replacement therapy for menopausal symptoms, and in the treatment of gynecological
These include Ortho Tri-Cyclen, Estrostep, Beyaz, and YAZ. [65] [66] [67] Hirsutism is the growth of coarse, dark hair where women typically grow only fine hair or no hair at all. [68] This hair growth on the face, chest, and abdomen is also mediated by higher levels or action of androgens.
[48] [51] [49] About 5 to 10% of women experience negative mood changes with combined birth control pills, and about 5% of women discontinue birth control pills due to such changes. [ 52 ] [ 48 ] A study of about 4,000 women found that progestogen-only birth control with depot medroxyprogesterone acetate had an incidence of depression of 1.5% ...
Norelgestromin is available only as a transdermal contraceptive patch in combination with ethinyl estradiol. [6] The Ortho Evra patch is a 20 cm 2, once-weekly adhesive that contains 6.0 mg norelgestromin and 0.6 mg ethinyl estradiol and delivers 200 μg/day norelgestromin and 35 μg/day ethinyl estradiol.
In 2010, Ortho-McNeil pled guilty in U.S. District Court to one count of misdemeanor violation of the Food, Drug & Cosmetic Act for illegally promoting its epilepsy drug Topamax for uses that were not approved by the FDA. The company was charged with using a program called "Doctor for a Day" to promote Topamax to psychiatrists for treatment of ...